11th Dec. 2020: To ensure the safety and efficacy of the public health, Central Drugs Standard Control Organization (CDSCO) under Ministry of Health & family Welfare, Govt. of India issued alert notice in their public domain regarding harmfulness of a particular medicine which was failed in test/ analysis in Govt. Laboratory (NABL Accredited Laboratory).
In the same way it is to mention that the drug/ medicine which comes under the category of “Not of Standard Quality” (NSQ), Adulterated or Spurious after test/ analysis a circular issued around across the country to stop sale/ distribution in the market and further use of that type of medicine/ drug may cause of ill health or damage the body or may cause of death also.
The Drugs Controller General (India) has shared the information for awareness of the common public for restriction of use of the medicine ROOTCAL (Calcium Citrate Maleate & Vitamin D3, Tablets), Batch No. RTC-1910
Drug/ Medicine Name: ROOTCAL (Calcium Citrate Maleate & Vitamin D3 Tablets)
Batch No. RTC-1910
Manufactured by: Concord Drugs Ltd., Survey No. 249, Brahmanapally, R.R. (DT) TS- 501 511, Hyderabad, Telangana
The above mentioned drug/ medicine is declared “Not of Standard Quality” by the Govt. Analyst, Central Drugs Laboratory (CDL), 3, Kyd Street, Kolkata- 700 016.
The drug, ROOTCAL (Calcium Citrate Maleate & Vitamin D3 Tablets) is failed in the test for *Disintegration and *Assay of Vitamin D3, as a result, it is to state that, use of the drug/ medicine is harmful to health and it may cause death also.
The drug, ROOTCAL (Calcium Citrate Maleate & Vitamin D3 Tablets) was drawn by the Drugs Inspector, Govt. of India representative at CDSCO (Zonal Office), Hyderabad, address: CDSCO BHAVAN, Beside T.B. & Demonstration Centre, S.R. Nagar, Hyderabad-500 038, Andhra Pradesh, India and forwarded to Central Drugs Laboratory, 3, Kyd Street, Kolkata- 700 016 for Test and Analysis.
Why should not to be taken the drug/ medicine ?
The drug/ medicine, ROOTCAL (Calcium Citrate Maleate & Vitamin D3 Tablets) after test/ analysis, the Govt. Analyst declared the drug is failed to comply with the condition specified under Drugs & Cosmetics Act, 1940. The Govt. Analyst also remarked the drug sample does not conform to IP with respect to test for Disintegration and Assay of Vitamin D3.
*Disintegration test: The test determines whether dosage forms such as tablets, capsules, boluses pessaries and suppositories disintegrate within a prescribed time, when placed in a liquid medium under the prescribed experimental condition.
*Assay test: An assay is an investigation procedure in laboratory medicine, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount or functional activity of target entity.